Esterified Estrogens Tablets
»Esterified Estrogens Tablets contain not less than 90.0percent and not more than 115.0percent of the labeled amount of esterified estrogens as the total of sodium estrone sulfate and sodium equilin sulfate.The ratio of sodium equilin sulfate to sodium estrone sulfate is not less than 0.071and not more than 0.20.
Packaging and storage—
Preserve in well-closed containers.
Disintegration á701ñ—
Simulated intestinal fluid—
Dissolve 6.8g of monobasic potassium phosphate in 250mLof water,mix,and add 190mLof 0.2Nsodium hydroxide and 400mLof water.Add 10.0g of pancreatin,mix,and adjust the resulting solution with 0.2Nsodium hydroxide to a pHof 7.5±0.1.Dilute with water to 1000mL.
Procedure—
Place 1Tablet in each of the six tubes of the basket,and immerse the basket in water at 25±0.5
for 5minutes to remove the coating.Add a disk to each tube,and operate the apparatus using simulated gastric fluid TS,maintained at 37±2,as the immersion fluid.After 30minutes in simulated gastric fluid TS,lift the basket from the fluid,and observe the Tablets:all the Tablets have disintegrated.If all the Tablets have not disintegrated completely,substitute Simulated intestinal fluid,maintained at 37±2,as the immersion fluid,and continue the test so that the total period of time,including previous exposure to water and simulated gastric fluid TS,does not exceed 90minutes.
for 5minutes to remove the coating.Add a disk to each tube,and operate the apparatus using simulated gastric fluid TS,maintained at 37±2,as the immersion fluid.After 30minutes in simulated gastric fluid TS,lift the basket from the fluid,and observe the Tablets:all the Tablets have disintegrated.If all the Tablets have not disintegrated completely,substitute Simulated intestinal fluid,maintained at 37±2,as the immersion fluid,and continue the test so that the total period of time,including previous exposure to water and simulated gastric fluid TS,does not exceed 90minutes.
Uniformity of dosage units—
Assay 10individual Tablets as directed in the Assay,and calculate the average content of esterified estrogens,as the average of the total contents of sodium estrone sulfate and sodium equilin sulfate,in the 10Tablets.The requirements are met if the content of each of the Tablets is not less than 85.0percent and not more than 115.0percent of the average content of esterified estrogens.If the content of not more than 2Tablets falls outside the range of 85.0percent to 115.0percent of the average content but not outside the range of 75.0percent to 125.0percent,assay an additional 20Tablets.The requirements are met if the content of not more than 2of the 30Tablets falls outside the limits of 85.0percent and 115.0percent of the average,and no unit is outside the range of 75.0percent to 125.0percent of the average content.
Assay—
Weigh and finely powder not less than 20Tablets.Using a suitable portion of the powder,proceed as directed in the Assayunder Conjugated Estrogens.
Auxiliary Information—
Staff Liaison:Clydewyn M.Anthony,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 780
Phone Number:1-301-816-8139